Events

Recall of Varian RPM System version 1.7.3

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45519
  • Event Risk Class
    Class 2
  • Event Number
    Z-0554-2008
  • Event Date Posted
    2008-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65722
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Linear Medical Accelerator - Product Code IYE
  • Reason
    Erroneously resetting: rpm system version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. rpm 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the session options during the treatment session. this can lead to difference between the planned and delivered.
  • Action
    Varian sent an Urgent Medical Device Correction letter on September 26, 2007, to all its direct consignees, informing them that the RPM version 1.7 may reset the phase thresholds if Sessions options are accessed during treatment. A Service Representative will be scheduling a visit to user site to perform the modification requested to address the problem, when a corrected software version is available.

Device

Varian RPM System version 1.7.3
  • Model / Serial
    Serial Number:  H502244, H502211, H502203, H502183, H502179, H502178, H502169, H502167, H502166, H502154, H502152, H502138, H502137, H502136, H502133, H502132, H502131, H502130, H502126, H502121, H502119, H502118, H502117, H502116, H502112, H502110, H502107, H502104, H502103, H502102, H502096, H502060, H502057, H502045, H502002, H501999, H501983, H501930, H501907, H501904, H501869, H501838, H501577, H501412, H501367, H501329, H501325, H501306, H501290, H501259, H501246, H501222, H501214, H502051, H502067, H500395, H500406, H500853, and H502066
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including countries of: Ireland, Italy, Spain, UK, Denmark, Finland, France, and Canada
  • Product Description
    Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • Manufacturer Address
    Varian Medical Systems Inc, 911 Hansen Way, Palo Alto CA 94304
  • Source
    USFDA